〝基立福〞乾燥第九凝血因子注射劑

Država: Tajvan

Jezik: kineski

Izvor: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktivni sastojci:

FACTOR IX

Dostupno od:

台灣綠十字股份有限公司 台北市大同區承德路三段二四四號六樓 (71621557)

ATC koda:

B02BD04

Farmaceutski oblik:

凍晶注射劑

Sastav:

FACTOR IX (2012100700) 400-625IU (I

Jedinice u paketu:

盒裝附注入器;;小瓶;;護蓋

Razred:

菌　疫

Tip recepta:

限由醫師使用

Proizveden od:

GRIFOLS BIOLOGICALS LLC 13111 TEMPLE AVENUE, CITY OF INDUSTRY, CA 91746, USA US

Područje terapije:

coagulation factor IX

Terapijske indikacije:

預防及治療乙型血友病及缺乏第九凝血因子。

Proizvod sažetak:

有效日期: 2028/05/20; 英文品名: ALPHANINE SD COAGULATION FACTOR IX(HUMAN)

Datum autorizacije:

1998-11-30

Uputa o lijeku

RTA #88
18 13/16”
13 11/16”
BAR CODE
Coagulation Factor IX (Human)
AlphaNine
®
SD
Solvent Detergent Treated and Virus Filtered
DESCRIPTION
Coagulation Factor IX (Human), AlphaNine
®
SD, is a purified, solvent detergent treated, virus fiItered
preparation of
Factor IX derived from human plasma.
1
It contains a minimum of 150 lU Factor lX/mg protein; levels of Factor
VII
(proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower
Factor) which are below the limit of detection (less than
0.04 Factor VII unit, less than 0.05 Factor II unit, and less than
0.05 Factor X unit per IU Factor IX). AlphaNine SD is a steriIe,
IyophiIized preparation intended for intravenous administration only.
Each vial is a single dose container.
AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT
0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and
NMT 0.l0 μg tri(n-butyl) phosphate/IU of Factor IX.
CLINICAL PHARMACOLOGY
AlphaNine SD is a purified formulation of Factor IX containing not
less than 150 IU Factor IX activity/mg of total protein.
2
AlphaNine SD contains non-therapeutic levels of Factor II, Factor VII
and Factor X.
Thrombogenicity of AlphaNine SD in animals is markedly lower than that
of Factor IX Complex, Profilnine
®
Heat-Treated.
Five lots of AlphaNine SD (three lots of non-virus filtered product
and two lots of virus filtered product) failed to show
any evidence of thrombogenicity when tested directly in the Wessler
rabbit stasis model for thrombogenicity
3-6
at a dose
of 200 IU Factor IX/kg body weight. When various lots of AlphaNine SD
were further tested at doses between 300 and 650 IU
Factor IX/kg, only 5 out of 40 animals (12.5%) showed evidence of
thrombus formation (Wessler scores of +1, +2, +1,
+1, +1 out of +4 maximum). In comparison, Factor IX Complex
concentrate, Profilnine, was thrombogenic in 100% of the
animals tested at a dose of 100 IU Factor IX/kg.
At a dose of 200 IU Factor IX/kg body weight in a porcine model, the
heptane heat-treated formulation of this product
(AlphaNine)